effects of biological treatment on blood pressure and endothelial function in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis

Conditions: Rheumatoid Arthritis; Psoriatic Arthritis; Ankylosing Spondylitis; Hypertension

Summary: the aim of this study is to evaluate the influence of anti tumor necrosis factor-alpha (tnf-α) treatment on blood pressure, endothelial function and immune cell phenotype in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.


Eligibility criteria:
inclusion criteria: for patients suffering from rheumatoid arthritis: * rheumatoid arthritis diagnosed based on the american rheumatism association criteria from 1987 * ineffective treatment with 2 disease-modifying antirheumatic drugs (dmards) for 6 months each, including treatment with maximal doses of methotrexate for at least 3 months (or intolerance to treatment) * high disease activity - disease activity score 28 (das 28) \> 5,1 measured twice, with a 1-month interval * for patients with mainly lower limbs affected with das 28 \> 3,7 for patients suffering from ankylosing spondylitis: * ankylosing spondylitis diagnosed based on modified new york criteria * ineffective treatment with 2 non-steroidal anti-inflammatory drugs (administered separately) in maximal recommended or maximal tolerated dose for 3 months * high disease activity -bath ankylosing spondylitis disease activity index (basdai) \> 4 measured twice, with a 12-week interval * spinal pain \> 4cm on 10cm visual analogue scale (vas) measured twice, with a 12-week interval * general disease activity assessment \> 5 (0-10 scale) performed after the 2nd vas and basdai assessment for patients suffering from psoriatic arthritis: - psoriatic arthritis diagnosed based on the bennett or classification criteria for psoriatic arthritis (caspar criteria) if peripheral joints are affected: active disease assessed twice, with a 4-week interval on stable treatment, after 2 dmards treatment for at least 4 months criteria of active disease (all have to be met): * at least 5 out of 66 joints swollen - assessed twice, with a 4-week interval * at least 5 out of 68 joints tender - assessed twice, with a 4-week interval * general disease activity assessment of 4 or 5 in the likert scale (0- 5 scale) performed by patient * general disease activity assessment of 4 or 5 in the likert scale (0- 5 scale) performed by physician * general disease activity assessment \> 5 (0-10 scale) performed after 2nd assessment of number of tender and swollen joints if axial joints are affected: * sacroiliac joints affected according to the new york criteria of ankylosing spondylitis * active and severe disease assessed twice, with a 12-week interval, stable treatment, ineffective treatment with 2 nonsteroidal anti-inflammatory drugs (administered separately) in maximal recommended or maximal tolerated dose for 3 months each criteria of active disease (all must be present): * basdai \> 4 measured twice, with a 12-week interval * spinal pain \> 4cm on 10 cm in the vas measured twice, with a 12-week interval * general disease activity assessment \> 5 (0-10 scale) patients can take steroid in stable dose within one month - maximal dose 10mg/day of prednisone. exclusion criteria: * non-consenting patient * pregnancy * breast-feeding * allergy for the drug or any component * cardiac insufficiency (nyha iii or iv) * active infection * infection within the last 3 months: hepatitis, pneumonia, pyelonephritis * opportunistic infection within the last 2 months: active infection of cytomegalovirus, pneumocystis carinii * joint infection within the last 12 months * endoprosthesis infection within the last 12 months or any time if the joint was not replaced * exacerbation of lung-, kidney-, liver- or heart insufficiency during treatment * demyelinating disease or its symptoms * pancytopenia or aplastic anemia * pre-cancer stage * neoplasm within the last 5 years including solid tumors and neoplasm of haematopoietic or lymphatic system with risk of recurrence or progression * active alcoholic disease * chronic liver disease